The following data is part of a premarket notification filed by Heinz Kurz Gmbh Medizintechnik with the FDA for Kurz Silicone Strips, Models Sf-1, Sf-1w, Sf-1 Bs.
| Device ID | K033796 |
| 510k Number | K033796 |
| Device Name: | KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-I Amsterdam, NL 1017 Ap |
| Contact | Angelika Scherp |
| Correspondent | Angelika Scherp HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-I Amsterdam, NL 1017 Ap |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-05 |
| Decision Date | 2004-01-30 |
| Summary: | summary |